- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05555979
A Study to Assess Change in Patient Experience in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets + Intravenous Rituximab or Bruton's Tyrosine Kinase Inhibitors Tablets in the United Kingdom (ELECTRIC)
Qualitative, Cross-sectional Observational Study Exploring the Experience of Patients Prescribed Venetoclax+Rituximab or Bruton's Tyrosine Kinase Inhibitors for Chronic Lymphocytic Leukaemia in Clinical Practice in the UK
Chronic lymphocytic leukemia (CLL), a form of Non-Hodgkin's Lymphoma, is the most common type of leukemia in adults, affecting approximately 3,800 people in the UK each year. This study will evaluate the patient experience of CLL in adult participants who are prescribed venetoclax+rituximab or Bruton's tyrosine kinase inhibitors in the United Kingdom (UK).
Venetoclax+rituximab is a drug approved to treat CLL. Study participants will receive venetoclax+rituximab as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed venetoclax+rituximab or Bruton's tyrosine kinase inhibitors will be enrolled. Around 140 participants will be enrolled in the study in approximately 10 sites in the UK.
Participants will receive venetoclax tablets to be taken by mouth and rituximab intravenous (IV) injection according to the approved local label.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leicester, United Kingdom, LE1 5WW
- University Hospitals of Leicester NHS Trust /ID# 252719
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London, United Kingdom, SW3 6JJ
- The Royal Marsden NHS Foundation Trust /ID# 252655
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Portsmouth, United Kingdom, PO6 3LY
- Portsmouth Hospitals University NHS Trust /ID# 252722
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Sunderland, United Kingdom, SR4 7TN
- Sunderland Royal Hospital /ID# 252495
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Taunton, United Kingdom, TA1 5DA
- Taunton and Somerset NHS Foundation Trust /ID# 252721
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London, City Of
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London, London, City Of, United Kingdom, E1 2ES
- Barts Health NHS Trust /ID# 252717
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Norfolk
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Norwich, Norfolk, United Kingdom, NR4 7UY
- Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252720
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
- Nottingham City Hospital /ID# 252716
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 9DU
- Oxford University Hospitals NHS Foundation Trust /ID# 252715
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West Sussex
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Worthing, West Sussex, United Kingdom, BN11 2DH
- University Hospitals Sussex NHS Foundation Trust /ID# 252672
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL) (as defined by 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute Working Group (IWCLL NCI-WG) Guidelines).
- Has relapsed/refractory (R/R) disease having received only 1 prior line of treatment, which must have been a chemotherapy or chemoimmunotherapy treatment.
- Has treatment experience with venetoclax+rituximab (Ven+R) or bruton's tyrosine kinase inhibitor (BTKi)s that meets the criteria for inclusion described in the protocol, for which recruitment targets have not yet been met.
Exclusion Criteria:
- Previously treated with a BTKi, a BCL-2 inhibitor or other investigational agents.
- Has any other medical condition or disorder that, in the opinion of the site investigator or study director, could compromise participant's ability to give written informed consent and/or prevent or interfere with his or her ability to comply with study procedures and provide meaningful information about his or her CLL experience.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Chronic Lymphocytic Leukemia (CLL) Participants
Participants treated with venetoclax+rituximab or bruton's tyrosine kinase inhibitors in accordance with approved local label.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants with a Change in Chronic Lymphocytic Leukemia (CLL) Symptoms
Time Frame: Day 1
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Number of participants who report a change in CLL symptoms through qualitative interviews.
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Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: ABBVIE INC., AbbVie
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Chronic Disease
- Disease Attributes
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Leukemia
- Leukemia, Lymphoid
- Leukemia, Lymphocytic, Chronic, B-Cell
Other Study ID Numbers
- P23-486
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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